CAI is seeking motivated CSV Specialists to support biotech and pharmaceutical projects in Puerto Rico. These individuals need to reside on the Island or relocate at their own expense for the duration of the contract. The duration begins July 2019 and continues until October 2019.
CAI is a 100% employee-owned company providing CQV, start-up, project management and consulting services to FDA regulated and mission critical industries. CAI was established in 1996 and has steadily grown to be an industry leader with 500 employees worldwide.
The Computer Systems Validation (CSV) Specialist will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
BS or higher in Computer Science/Information Systems & Technology/Engineering or related discipline.
Knowledge on computerized system with data collection software (database).
Knowledge with network communications protocol (i.e. TCP/IP)
Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations.
Acquainted with GAMP5 methodology for validations.
At least three (3) years of experience working with PLC’s, Industrial Computers and SCADA systems.
Background in pharmaceutical products manufacturing environment.
Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.
Bilingual in English/Spanish
Able to travel domestically and internationally as required
Able to work in the US without sponsorship now or any time in the future.